FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSTAFIL
K Number: K810795
·
Decision Jun 12, 1981
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
2
Review Days
81
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INSTAFIL
- K Number
- K810795
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Instafil, Inc.
- Date Received
- March 23, 1981
- Decision Date
- June 12, 1981
- Product Code
- KPE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPE | Container, I.V. | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPE), ordered by most recent decision date.
Disposable Infusion Bag for Parenteral Nutrition
FDA 510(k)
FDA Class 2
·General Hospital
ClaveQS Bag
FDA 510(k)
FDA Class 2
·General Hospital
KabiHelp® Uno; KabiHelp® Advance plus
FDA 510(k)
FDA Class 2
·General Hospital
eZSURE Empty Fluid Container
FDA 510(k)
FDA Class 2
·General Hospital
DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
FDA 510(k)
FDA Class 2
·General Hospital
eZSURE Empty Fluid Container with ProSeal Injection Site
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Instafil, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872446 | MODIFIED INSTAFIL | Aug 25, 1987 | Substantially Equivalent |